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BeiGene Prices TEVIMBRA 10% Below Competitors Following FDA Approval for Esophageal Cancer Treatment
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BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced the commercial availability of TEVIMBRA (Tislelizumab) in the United States following its approval by the FDA for the treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy. The drug received FDA approval in March…
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Unixell Advances in Cell Therapy with CDE IND Acceptance
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Shanghai-based Unixell Biotechnology Co., Ltd. has announced that its Investigational New Drug (IND) application for “UX-DA001 Injection (Human Midbrain Dopaminergic Neuronal Precursor Cell Injection)” has been accepted by the Center for Drug Evaluation (CDE). The therapy, which aligns with the company’s inaugural pipeline, is speculated to target Parkinson’s disease. Founded…
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Duality Biotherapeutics’ BDCA2 ADC DB-2304 Phase I Trial Registered on ClinicalTrials.gov
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Duality Biologics, Inc., a biopharmaceutical company specializing in the development of innovative therapies, has registered a Phase I clinical trial for its drug candidate DB-2304 on ClinicalTrials.gov as of October 3, 2024. The trial is designed to enroll 70 healthy volunteers and is anticipated to conclude in the first half…
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BeiGene’s FGFR2b ADC BG-C137 Enters Phase I Clinical Trial for Advanced Solid Tumors
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On October 3, 2024, BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) registered a Phase I clinical trial for BG-C137, an antibody-drug conjugate (ADC) for the treatment of advanced solid tumors, on ClinicalTrials.gov. The trial plans to enroll 68 patients with advanced solid tumors and is expected to be completed by…
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BMS Expands Opdivo Indication with FDA Approval for NSCLC Combo Therapy
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The U.S. Food and Drug Administration (FDA) has granted approval for Bristol Myers Squibb’s (BMS, NYSE: BMY) Opdivo (nivolumab) for use in combination with platinum-based chemotherapy as a neoadjuvant treatment for adult patients with resectable non-small cell lung cancer (NSCLC), followed by Opdivo as an adjuvant treatment post-surgery. This decision…
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InnoCare Pharma’s Orelabrutinib Achieves Milestone in SLE Clinical Trial Enrollment
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InnoCare Pharma announced on October 4, 2024, that it has completed patient enrollment in a Phase II clinical trial for its novel BTK inhibitor, Orelabrutinib, for the treatment of Systemic Lupus Erythematosus (SLE). This randomized, double-blind, placebo-controlled, multicenter Phase IIb clinical study is designed to evaluate the efficacy and safety…
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Akeso Biopharma’s PD-1/VEGF Bispecific Antibody Study Completes Enrollment
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On October 4, 2024, Summit Therapeutics (referred to as “Summit”), a partner of Akeso Biopharma (HKG: 9926), announced the completion of subject enrollment for the HARMONi study, which evaluates the PD-1/VEGF bispecific antibody, Ivociclib (also known as AK112). The international Phase III clinical study is led by Summit and investigates…
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FRα ADC Rina-S by Genmab Enters Late-Stage Clinical Trial Following ProfoundBio Acquisition
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Genmab A/S (NASDAQ: GMAB) has initiated a Phase III clinical trial for its FRα ADC candidate, Rina-S, as registered on ClinicalTrials.gov on October 1, 2024. The trial aims to enroll 530 patients with platinum-resistant advanced ovarian cancer to compare Rina-S head-to-head with chemotherapy, with an anticipated preliminary completion date in…
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Dizal Pharmaceutical’s Surufatinib Earns CDE Consideration for Breakthrough Therapy in EGFR exon20ins NSCLC
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Dizal Pharmaceutical, a biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) in China is considering its drug candidate DZD9008 for breakthrough therapy status. The drug is designed to treat patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not received…
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Hengrui Pharmaceuticals’ HR19042 Capsules Designated as Breakthrough Therapy for Autoimmune Hepatitis by China NMPA
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The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has recently announced that Hengrui Pharmaceuticals (SHA: 600276)’s Class 2.2 improved drug, HR19042 capsule, is planned to be included in the breakthrough therapy category, targeting active autoimmune hepatitis. According to previous announcements by Hengrui Pharmaceuticals, HR19042 is…
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NMPA Clears AbbVie’s ABBV-706 for Clinical Trials Targeting SCLC and Neuroendocrine Tumors
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The China National Medical Products Administration (NMPA) has granted clinical trial approval to ABBV-706, a novel antibody-drug conjugate (ADC) developed by AbbVie (NYSE: ABBV), for the treatment of relapsed/refractory small cell lung cancer (SCLC) and other neuroendocrine tumors . ABBV-706 is a targeted therapy that binds to SEZ6, a protein…
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Jiangsu Alphamab Biopharmaceuticals Partners with Shanghai Jinmant Biotech for JSKN003 ADC
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Alphamab Oncology (HKG: 9966), a biopharmaceutical company based in China, has announced that its wholly-owned subsidiary, Jiangsu Alphamab Biopharmaceuticals Co. Ltd, has entered into a licensing agreement with Shanghai Jinmant Biotech Co., Ltd, a subsidiary of CSPC Pharmaceutical Group Co., Ltd (HKG: 1093), for the development and commercialization of its…
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CStone Pharmaceuticals’ Partner HengRui Medicine Launches Phase III Trial for CTLA-4 Antibody in HCC
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CStone Pharmaceuticals (HKG: 2616), an innovation-driven biopharmaceutical company focused on the development of oncology drugs, announced today that its partner, HengRui Medicine, has initiated a Phase III clinical study for CS1002/SHR-8068 (an anti-CTLA-4 monoclonal antibody) in combination with adebrelimab and bevacizumab for the first-line treatment of advanced hepatocellular carcinoma (HCC).…
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Zephyrm Bioscience Aims for HKEX Main Board with Innovative Cell Therapy Products
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Zephyrm Bioscience Limited (hereinafter referred to as “Zephyrm Bio”) officially submitted its prospectus to the Hong Kong Stock Exchange (HKEX) on September 30, 2024, with the intention to list on the Main Board, with CICC acting as the sole sponsor. Established in 2017, Zephyrm Bio, a clinical-stage biopharmaceutical company, is…
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Akeso Biopharma’s Cadonilimab Secures NMPA Approval for Gastric Cancer Indication
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Akeso Biopharma Inc. (HKG: 9926) announced that its self-developed PD-1/CTLA-4 bispecific antibody, Cadonilimab injection (AK104), has been approved by the National Medical Products Administration (NMPA) in China for a new indication. This is the second indication for the product in China and is for the first-line treatment of patients with…
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Alphamab Oncology Strikes Licensing Deal with CSPC Pharma for HER2 Targeted ADC in China
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Alphamab Oncology (HKG: 9966), a biopharmaceutical company based in China, has entered into a licensing agreement with fellow Chinese firm CSPC Pharmaceutical Group Ltd (HKG: 1093). The deal grants CSPC exclusive license and sub-license rights to Alphamab’s JSKN003 in mainland China for development, sales, and commercialization related to oncology indications.…
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Sichuan Biokin’s Partner Bristol-Myers Squibb Gets FDA Nod for Bispecific ADC Study
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a Chinese biopharmaceutical company, has announced that its U.S. partner Bristol-Myers Squibb has received approval from the U.S. Food and Drug Administration (FDA) to conduct a Phase I/IIa study for BL-B01D1, an in-house developed bispecific antibody drug conjugate (ADC), in patients with advanced…
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J&J’s Carvykti Shows 45% Reduced Risk of Death in Multiple Myeloma Patients, Landmark Trial Data Reveals
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Johnson & Johnson (J&J, NYSE: JNJ), a U.S.-based healthcare conglomerate, has released new clinical trial data for its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy, Carvykti (ciltacabtagene autoleucel). The data reveals long-term overall survival (OS) for the therapy’s use as a second-line treatment for multiple myeloma (MM). The three-year…
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Yabao Pharmaceutical’s SY-009 Receives NMPA Approval for Phase II Clinical Trial in Constipation
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Yabao Pharmaceutical Group Co., Ltd (SHA: 600351), a Chinese pharmaceutical company, has announced that SY-009 capsules, a sodium-glucose linked transporter-1 (SGLT-1) inhibitor co-developed with Eli Lilly & Co., (NYSE: LLY) have received approval from the National Medical Products Administration (NMPA) to proceed to a Phase II clinical study for the…
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Jiangsu Hengrui Pharmaceuticals Gets NMPA Green Light for Clinical Trial of TSLP-Targeted Asthma Treatment
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 product SHR1905, a thymic stromal lymphopoietin (TSLP)-targeted monoclonal antibody (mAb). The product is…
